Orthopedic surgical hammertoe instrument recalled for improper component sizing
Nextremity Solutions is recalling the Nextra Hammertoe Correction System due to an oversized driver component that makes it difficult to properly connect and remove during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device recall with no reported injuries or hospitalizations. This represents a risk-of-harm product where the manufacturing defect could impair surgical effectiveness, but no actual harm has been documented.
Plain-English summary
The Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit (SKU: NX-3532K), manufactured by Nextremity Solutions, is being recalled by the FDA due to a manufacturing defect affecting the proximal end of the driver.
The driver component is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant. This defect can cause delays during surgical procedures.
The recalled product was distributed in the United States, Japan, and the Netherlands. A total of 285 units were affected (Lot Number: 168125017A, UDI: 00817701020042).
The recalled product
- Product
- Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrument
- Manufacturer
- Nextremity Solutions
- Affected units
- 285
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 168125017A UDI: 00817701020042
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Nextremity Solutions under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Nextremity Solutions
See all →- HighOrthopedic Surgical Instrument Kit Recalled for Improper Driver Fit
FDA (Devices) · 2022-04-20
- HighOrthopedic surgical driver oversized, affecting hammertoe correction
FDA (Devices) · 2022-04-20
- HighNextra Hammertoe Correction System surgical instruments recalled for defective connector
FDA (Devices) · 2022-04-20
- HighHammertoe Correction Surgical System Recalled for Driver Connection Defect
FDA (Devices) · 2022-04-20
- HighNextra CH Hammertoe Surgical Implant Kit Recalled for Locking Mechanism Defect
FDA (Devices) · 2022-03-16
Similar recalls
- HighNextremity Solutions Recalls Nextra Hammertoe Correction System Due to Driver Defect
FDA (Devices) · 2020-03-18
- HighNextra CH Hammertoe Surgical Implant Kit Recalled for Locking Mechanism Defect
FDA (Devices) · 2022-03-16
- HighSurgical hammertoe instruments recalled for potential locking mechanism deformation
FDA (Devices) · 2022-03-16
- HighBiomet Recalls Phoenix Retrograde Femoral Connecting Bolts Due to Fit Issues
FDA (Devices) · 2013-06-26
- ModerateNextremity Solutions Recalls Stratum Foot Plating System Screws Due to Incorrect Specifications
FDA (Devices) · 2019-12-04
- ModerateNextremity Solutions Recalls Stratum MDS Screws Due to Length Discrepancy
FDA (Devices) · 2020-01-15